Annex 1: Overview of the research governance procedure for researchers

INITIAL DECISIONS STAGE:

1 Decide if the project is a health care research project

(consult:

Decide which organisation is the project’s research governance sponsor
(consult:

Decide if an honorary research contract or letter of access is needed and, therefore, whether the Research Passport application form needs completing

(consult the guidance:

REGISTRATION STAGE:

2Register the project on the University Research Management System (URMS)

(consult:
or contact )

AND IF THE PROJECT INVOLVES THE NHS THEN ALSO

Register the project with the NHS Trust(s) and/or Primary Care Trust(s) which are involved

(the list of Trust R&D contacts is at:

-RIS’s Pricing & Contracts team is notified about all studies registered with the STH Trust-

3 APPLY FOR APPROVALS STAGE:

APPLY FOR INDEPENDENT SCIENTIFIC REVIEW

Submit application to the research funder (the funder will normally peer review it)

orapply for scientific peer review within the University
(consult:

AND APPLY FOR INDEPENDENT ETHICS REVIEW:

Either Apply for ethics review via the NHS National Research Ethics Service

(complete the application form from the IRAS website:

consult:

All projects need to enclose with their NHS ethics application a certificate of insurance

(consult:

or

Apply for ethics review via the University’s ethics review procedure
(consult:

AND ALSO APPLY FOR NHS R&D REVIEW IF THE PROJECT INVOLVES THE NHS:

Apply for NHS R&D review in order to obtain NHS permission/R&D approval

(complete the study-wide R&D form and the local SSI form from the IRAS website, and submit them along with other documents which are listed in the checklist on the IRAS website)

4THE RESEARCH GOVERNANCE SPONSOR AUTHORISES THE PROJECT TO START

(Where the University is the research governance sponsor then written evidence of scientific approval & ethics approval is required. Where the University is not the research governance sponsor then written confirmation is required from the organisation that has agreed to be the research governance sponsor of its agreement to be the sponsor).

Guidance on the post-award requirements is at: